High-dose chemotherapy with transplantation of gene-modified haematopoietic stem cells for HIV-positive patients with malignant diseases indicating an HSCT
- Conditions
- HIV-positive patients with any malignant disease of the haematopoietic system indicating haematopoietic stem cell transplantation (autologous or allogeneic)MedDRA version: 12.1Level: LLTClassification code 10061624Term: AIDS related complication
- Registration Number
- EUCTR2005-003026-26-DE
- Lead Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Male and female patients of any ethnic group aged between 18 and 65 years
•HIV-positive patients with malignant diseases of the blood (NHL, Hodgin disease,
plasmocytoma, acute and chronic leukaemia) indicating an HSCT:
- M.Hodgkin: autologous SCT for relapsed patient, allogeneic SCT for relapse
after autologous SCT or primary refractory disease or insufficient autologous
stem cell collection
- High grade NHL: autologous SCT for relapsed patient, allogeneic SCT for
relapse after autologous SCT or primary refractory disease or insufficient
autologous stem cell collection
- Low grade NHL: autologous SCT for relapse after first or second line
treatment, allogeneic SCT for relapse after autologous SCT
- Multiple Myeloma: autologous SCT for chemosensitiv or chemorefractory
diseases, allogeneic SCT for relapse after autologous SCT
- AML: allogeneic SCT for 1. CR with high risk cytogenetic, refractory disease or
remissionstatus > 1. CR
- ALL: allogeneic SCT for high risk or very high risk disease , non complete or
> 1.CR
- CML: allogeneic SCT for patient resistant to tyrosine kinase inhibitor treatment
•Patients must receive HAART
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Any of the following conditions: congestive heart failure (NYHA > II), documented EBV, HBV or HCV infection (only for allogeneic PBSCT), creatinine clearance < 60 ml/min, left ventricular ejection fraction < 40%, bilirubin > 2 mg/dl
•Severe opportunistic infection
•More than 10% of bone marrow involved with lymphoma
•Between 2 and 5 x 106 autologous CD34+ cells /kg body weight obtained after leukapheresis and CD34 enrichment
•Women of child-bearing potential not under adequate contraceptive protection
•Women who are pregnant or breast feeding
•Known history of drug-, medication- or alcohol abuse within the last 12 months preceding the study
•Participation in another study with an investigational drug within less than one month prior to this study
•Simultaneous participation in a study with an investigational drug
•Presence of any disease likely to require procedures altering the schedule of this study
•Patients who are unable or unwilling to meet the requirements of the protocol
•Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator
•Patients with limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication
•Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular disease
•Patients who will not accept transfusions of blood products
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method